MedPath
FDA Approval

TRANEXAMIC ACID

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
July 21, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Tranexamic acid(100 mg in 1 mL)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

TRANEXAMIC ACID

Product Details

NDC Product Code
72485-107
Application Number
ANDA206713
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS
Effective Date
December 21, 2021
Code: 6T84R30KC1Class: ACTIBQuantity: 100 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
© Copyright 2025. All Rights Reserved by MedPath